FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema — DERMATUX  

Colorectal Cancer Metastatic Clinical Trial

Official title: Non-randomized Phase-IV-study to Investigate the Efficacy of FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

Status Active, not recruiting

Clinical Trial Summary

The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis.

Further Objectives:

1. Development of acneiforme follicular exanthema >= grade 2

2. Duration until development of acneiforme follicular exanthema >= grade 2

3. Development of paronychia

4. Development skin fissure (hand and foot)

5. Objective remission according RECIST 1.1

6. Rate of secondary resections of liver metastasis with a curative approach

7. Assessment of safety and tolerability

8. Overall survival

9. Progression free survival

Clinical Trial Description

Subjects with metastatic colorectal cancer and confirmed KRAS-wildtype status in 1st line therapy will be included in this phase IV-study. Subject will receive a regimen of FOLFIRI in combination with Cetuximab every two weeks during study treatment phase. Treatment continues until

• disease progression

• complete response

• development of status of operability

• an uncontrollable exanthema grade 3 or 4 or

• intolerable toxicity is diagnosed. After study discontinuation or end of treatment, respectively, patients will be followed up until the the last patient was treated for 12 months and has completed the 36-months follow up phase. Tumor response will be evaluated (according to RECIST 1.1) every 12 weeks and at the end of study treatment ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms
• Exanthema

• NCT number: NCT01315990
• Study type: Interventional
• Source: Johannes Gutenberg University Mainz
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 2011
• Completion date: March 2018